Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer

NCT05244577 | Unknown Phase 3

• 1 other identifier: 2021-FXY-268
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy and safety of olanzapine combined with fosaprepitant, ondansetron and dexamethasone compared with placebo combined with fosaprepitant, ondansetron and dexamethasone in the prevention of nausea and vomiting in germ-cell tumors receiving 5-day cisplatin chemotherapy

Conditions

Olanzapine; CINV; Testicular Cancer by AJCC V6 and V7 Stage; Cisplatin

Keywords

testicular cancer; olanzapine; Cisplatin 5-day regimen; Nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response From 0 to 240 Hours After Initiation chemotherapy

  Complete Response was defined as no vomiting and no use of rescue medication

  1 to 10 days

Secondary Outcomes (6)

• Percentage of Participants With minimal nausea

  1-10 days

• Percentage of Participants with total control

  1 to 10 days

• Severity of nausea

  1 to 10 days

• Number of rescue medications

  1 to 10 days

• Time to Treatment Failure in each group of participates

  1 to 10 days

Study Arms (2)

Olanzapine

EXPERIMENTAL

Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Olanzapine 5mg Po D1-7

Drug: Olanzapine Tablets

Placebo

PLACEBO COMPARATOR

Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Placebo 5mg Po D1-7

Drug: Placebo

Interventions

Olanzapine Tablets DRUG

Olanzapine,Ondansetron,Dexamethasone,Fosaprepitant

Also known as: Olanzapine

Olanzapine

Placebo DRUG

Placebo,Ondansetron,Dexamethasone,Fosaprepitant

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology confirmed germ cell tumor (both spermatogonoma and non-spermatogonoma) and had no chemotherapy before;
• Men;
• Age ≥16 years old;
• ECOG score of physical status 0-2;
• Chemotherapy regimen containing 5-day cisplatin (20mg/m2, 100mg total;
• No other nausea, vomiting, or use of any antiemetics within 72 hours prior to enrollment;
• There are no clear brain metastases or other reasons for long-term systemic use of hormones;
• The general condition is good, and the blood, liver and kidney functions meet the following standards:
• Hemoglobin: 90 g/L and above White blood cell count: 3.5 \* 109 / L - 10.0 \*109 / L Neutrophil count: 1.5\* 109/L or above Platelet count: 90\* 109/L or above Serum total bilirubin: below 1.5 times the upper limit of normal Serum AST, ALT and ALP: the upper limit of normal is below 2.5 times when the patient is present
• Ability to read, understand and complete research questionnaires and journals, including visual analog scale (VAS);
• Understand the study procedure and sign the informed consent in person to participate in the study

You may not qualify if:

• Patients who meet any of the following criteria will be excluded:
• Digestive tract obstruction, water and electrolyte disorder;
• Have central nervous system diseases (such as primary brain tumors, uncontrolled seizures, any history of brain metastases or strokes);
• Contraindications to the use of glucocorticoids: ① Viral, bacterial, fungal and other infections that cannot be controlled by antibiotics;② Active gastric or duodenal ulcer;③ Severe hypertension, arteriosclerosis, diabetes; ④ Osteoporosis;⑤ Corneal ulcer;⑥Trauma or surgical repair period, fracture; ⑦Adeno-cortical hyperfunction; ⑧Severe mental illness and epilepsy; ⑨ patients with cardiac or renal dysfunction;
• In addition to malignancy, the patient has an active infection (e.g. pneumonia, hepatitis) or any uncontrolled infection diseases (such as diabetic ketoacidosis), and the researchers believe may contribute to the study's findings confounding, or exposing patients receiving study drugs to unnecessary risks;
• The patient is currently using any prohibited drugs, including medicinal marijuana or is currently using alcohol (Chinese Diagnostic criteria for drug dependence);
• The patient received an unapproved (experimental) drug treatment within the past 4 weeks;
• Taking oral olanzapine or other psychotropic drugs;
• A history of hypersensitivity to fosappitan, 5-HT3 receptor antagonists or dexamethasone;
• The patient cannot swallow the drugs;
• The principal investigator considered the patients unsuitable for the study;
• Inability or unwillingness to adhere to research protocols

Sponsors & Collaborators

• Shi Yanxia: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (9)

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  PMID: 32133645 BACKGROUND

• Herman TS, Einhorn LH, Jones SE, Nagy C, Chester AB, Dean JC, Furnas B, Williams SD, Leigh SA, Dorr RT, Moon TE. Superiority of nabilone over prochlorperazine as an antiemetic in patients receiving cancer chemotherapy. N Engl J Med. 1979 Jun 7;300(23):1295-7. doi: 10.1056/NEJM197906073002302.

  PMID: 375088 BACKGROUND

• Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, Chawla SP, Carides AD, Ianus J, Elmer ME, Evans JK, Beck K, Reines S, Horgan KJ; Aprepitant Protocol 052 Study Group. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003 Nov 15;21(22):4112-9. doi: 10.1200/JCO.2003.01.095. Epub 2003 Oct 14.

  PMID: 14559886 BACKGROUND

• Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006 Jun;17(6):1000-6. doi: 10.1093/annonc/mdl019. Epub 2006 Mar 8.

  PMID: 16524979 BACKGROUND

• Albany C, Brames MJ, Fausel C, Johnson CS, Picus J, Einhorn LH. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012 Nov 10;30(32):3998-4003. doi: 10.1200/JCO.2011.39.5558. Epub 2012 Aug 20.

  PMID: 22915652 BACKGROUND

• Ioroi T, Furukawa J, Kume M, Hirata S, Utsubo Y, Mizuta N, Miyake H, Fujisawa M, Hirai M. Phase II study of palonosetron, aprepitant and dexamethasone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy. Support Care Cancer. 2018 May;26(5):1419-1423. doi: 10.1007/s00520-017-3967-2. Epub 2017 Nov 16.

  PMID: 29147855 BACKGROUND

• Olver IN, Grimison P, Chatfield M, Stockler MR, Toner GC, Gebski V, Harrup R, Underhill C, Kichenadasse G, Singhal N, Davis ID, Boland A, McDonald A, Thomson D; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy. Support Care Cancer. 2013 Jun;21(6):1561-8. doi: 10.1007/s00520-012-1696-0. Epub 2012 Dec 30.

  PMID: 23274926 BACKGROUND

• Grunberg S, Chua D, Maru A, Dinis J, DeVandry S, Boice JA, Hardwick JS, Beckford E, Taylor A, Carides A, Roila F, Herrstedt J. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE. J Clin Oncol. 2011 Apr 10;29(11):1495-501. doi: 10.1200/JCO.2010.31.7859. Epub 2011 Mar 7.

  PMID: 21383291 BACKGROUND

• Hashimoto H, Abe M, Tokuyama O, Mizutani H, Uchitomi Y, Yamaguchi T, Hoshina Y, Sakata Y, Takahashi TY, Nakashima K, Nakao M, Takei D, Zenda S, Mizukami K, Iwasa S, Sakurai M, Yamamoto N, Ohe Y. Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Feb;21(2):242-249. doi: 10.1016/S1470-2045(19)30678-3. Epub 2019 Dec 11.

  PMID: 31838011 BACKGROUND

MeSH Terms

Conditions

Testicular Neoplasms; Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yanxia Shi, PHD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Shi, PHD

CONTACT

+8613609058827; shiyx@sysucc.org.cn

Xin An, PHD

CONTACT

+8613650798675; anxin@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 17, 2022
• Study Start: January 18, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)